12866 MEETINGS
https://www.reginfo.gov/public/do/eom12866SearchResults?pubId=202104&rin=0938-AU17&viewRule=true
ABBOTT DECK
https://www.reginfo.gov/public/do/eoDownloadDocument?pubId=&eodoc=true&documentID=89792
MEDTRONIC DECK
https://www.reginfo.gov/public/do/eoDownloadDocument?pubId=&eodoc=true&documentID=90043
Medtronic-OMB Meeting on CGM in DMEPOS Proposed Rule -- 11-23-2021 -- FINAL.pdf
Abbott - 19Nov2021 Meeting re CGM Access.pdf
Novitas Draft LCD PGX DL39063
Comment June 10 - July 24
Novitas Final LCD PGX L39063 (Oct 28)
Comment October 28; Effective December 12
Billing and Coding A58801
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58801&ver=9
Response to Comments
A58929
https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=58929&ver=3
Novitas Anti Fraud Article
http://www.discoveriesinhealthpolicy.com/2021/10/novitas-article-attacks-genetics.html
Operation Double Helix
From webinar at USC on 10/27/2021 with Scott Gottlieb and Joe Grogan.
http://www.discoveriesinhealthpolicy.com/2021/10/very-brief-blog-joe-grogans-blog-on.html
AUTO TRANSCRIPT (Not corrected)
ERIN TRISH
Great, thank you. So I think, you know, you both have
touched on the the kind of value of getting new therapies or new diagnostics or
new treatments to patients quickly. And that's, you know, quite obvious during
a pandemic, why we see such value there.
But, you know, switching gears a bit, I think there is a lot
of value to getting new therapies or diagnostics to patients with unmet need,
even beyond the pandemic setting.
So, Joe, you recently, you know, you did a nice job at the
beginning of laying out the differences between reimbursement for devices and
how that differs from the drug reimbursement or coverage pathways. But
ultimately, you know, you recently wrote a blog post that described one of the
rules that was moved forward under the Trump administration during your time
there that was really pushing to accelerate coverage for innovative
technologies for Medicare patients, on the exit rule that was moved forward and
finalized during the Trump administration, but recently pulled back under the
Biden administration out of raising some concerns. So can you describe kind of
what were the goals? Or what were you trying to achieve with that policy? And
what are some of the reasons why the Biden ministration is concerned with it
today?
JOE GROGAN
Well, we were talking trying to do is get innovative
technologies out to the marketplace as quickly as possible. So it's called the
Medicare coverage and innovative, innovative technologies will and basically,
it laid out that FDA designated device is breakthrough and then approves it, it
would automatically be covered at on the CMS site, not every device, not every
diagnostic, a small subset that was determined to be breakthrough would be
covered. And that would short circuit, some of the bureaucratic hurdles that
CMS erected to getting these out into the marketplace to the Medicare
population, you would still have to figure out how much this product would get
reimbursed for and go through. But that whole coverage, reasonable and
necessary standard, which is different than safe and effective, and FDA would
be dispensed with frequently, CMS raises objections about various devices and
says they have to run their own trials and look at their own data and saying,
Oh, this isn't suitable for the Medicare population, the population that FDA
looked at was not representative Medicare. It's something certainly that device
companies, diagnostic companies need to look at when they're designing their
trials and figuring out hey, is this going to be suitable for CMS? Or am I
going to have to do a whole new series of trials after FDA review? And, and so
I think the reason why the Biden ministration didn't like this, and it was it
was controversial. And Peter Bach wrote a wrote a big long hit piece about
this, that this was going to be opening the floodgates to dangerous products,
getting into the market and all this stuff, which I categorically disagree
with. I mean, FDA, I have faith in the FDA, to approve it on the CMS side, I
fail to see why you can't allow the marketplace to decide what is suitable or
not once FDA decided to did safe and effective, and frankly, the Biden
ministration wanted CMS to have more control over these products. We were more
sympathetic to innovation in and of itself and letting the market decide. I'm
hopeful that in the end, if the Biden ministration doesn't finalize some
version of this that Congress will step in common it's it's a provision a
similar provision is included included in the cures 2.0 bill which may go in
the spring, and that I think would be great for patients but but we were a
deregulatory administration. We were a deregulatory team and cutting out that
level of review was important to us. The last thing I'd say about that too is
the CMS staff who reviews these products at the various stages of coverage,
coding and reimbursement frequently speaks of being understaffed and not having
the technical expertise to review them. So this is another and finding people,
frankly, who are technically sound to review complicated devices is a is a
challenge at FDA to challenge and CMS, people like this don't don't grow on
trees, and they're very in demand in private industry. So having unnecessary
barriers because the bureaucracy can add qualified civil servants. We didn't
think was a was a was was reason to keep the product from patients.
SCOTT GOTTLIEB
Yeah, the the genesis of this idea was actually FDA, and it
came from the professional staff inside CDRH. And initial discussions were
directly with SEEMA VERMA about this. She, she faced opposition initially
inside CMS, not because I think they were philosophically opposed to it. But
the CMS didn't like the idea that professional staff there didn't like the idea
of giving up their discretion by tying their coverage decisions to a decision made
by FDA. So that, you know, CMS would effectively be forced to cover something
just because FDA gave it a breakthrough designation. And that would take their
discretion away. No, no agency likes to lose discretion. So the way we tried to
solve that was by giving CMS, you know, more of a seat at the table and in how
the breakthrough designations were determined as well. And that that seemed to
get us there. Sema was ultimately able to move this through her own agency, the
elegance of it was that not only was it sort of a presumption of coverage, but
that presumption of coverage was going to be worth a lot of money in terms of
foam was no cost, you were going to be able to finance this innovation much
more easily. So if you know a new device, new breakthrough device, got a
breakthrough designation, and there was a presumption that it was going to be
covered on the back end, if it was successful, that was going to make it much
easier to raise venture capital and get it financed in the private markets. And
so really, for no cost to the federal government, all of a sudden, they were
going to create a lot of Fiat investment, just by virtue of conferring a status
on something. And that's always kind of advantageous, you know, you don't have
to spend any money, but you can help promote a lot more capital formation. That
was the elegance of it. My My feeling is that the Biden administration's
decision to pull it was just gratuitous politics. There were some Democratic
interests against this, particularly among the payers, who thought it would
force them to have to cover technologies that they otherwise would have been
reluctant to cover, or being will exercise more discretion about covering and,
you know, they were pushing on the administration. And I think this was just an
example of a new administration coming in and unraveling a policy from the old
administration. I don't I don't think that there was sort of, based on what
I've not heard, any kind of like philosophical, really hard feelings about
this. I think this is was the kind of thing that kind of gratuitous
policymaking you sometimes see when administration's change over. So I agree
with Joe, I think that this could be done legislatively, I don't think that
there is a whole lot of opposition to it, you know, the bureaucracy could be
solved for their angst, I think the the payers just really isn't going to be a
big hit to the payers, the reality is, most of these, most of these
breakthrough products are going to get covered anyway. I mean, a vast majority
of them are going to get paid for just a question of how quickly they'll
they'll be paid for. So you know, it's not, it's hard to envision, and there
are some estimates on how much money this is going to cost. But there's always
seemed to be inflated to me, because most of these technologies will, will, in
fact, get covered because they are breakthrough, medical technologies that are
transformative from a healthcare standpoint.
This blog includes some informal notes secondary to an October 21, 2021, Discoveries in Health Policy blog about comments on the Fall 2021 MCIT rulemaking.
http://www.discoveriesinhealthpolicy.com/2021/10/mcit-rule-3rd-cycle-of-comments-now.html
The comments below are informal only and I apologize in advance if I have "mis-summarized" any key points.
As an alternative, see the blog link above and find the Zip file of full association comments in their original form.
Zip file
https://drive.google.com/file/d/16c9lCIxFdacRWQ3KJkR4d8E-Xcq2V437/view?usp=sharing
AAMC
Don't finalize MCIT because FDA studies lack enough Medicare population data.
Don't finalize R&N rule, due to references to commercial populations. Make any changes carefully.
ABBOTT
We support broader changes than MCIT. Create 60 day timelines for NCD requests and 90 day timelimes for implementing NCDs (not a year). Don't include blanket future non coverage language in NCDs. Rather, include language that future FDA indications are covered (without reopening NCD). Update a list of pending NCD requests frequently. Enact a CED time limit wherever CED is used (CMS actually proposed this itself, in the past). Use Parallel Review more.
Don't finalize R&N rule.
ACLA
This interesting comment focuses on the many vague aspects of the proposed R&N rule. (I made a short personal public comment to CMS on the same topic).
ADVAMED
In this 8 page comment, don't revoke the MCIT rule and AdvaMed will work with CMS to strengthen it. Make MCIT a voluntary opt-in program. Use Feedback between CMS and Mfgr to identify any issues CMS may have, collaborate with Mfgr on evidence development. AdvaMed is confident any operational issues raised by MCIT could be handled. Mfgrs can engage with CMS prior to the date of FDA approval (which itself is often a year or two or more after BT status is assigned by FDA in the review cycle).
Don't codify R&N.
AMP
Don't codify R&N; numerous issues cited. Don't refer to commercial insurance.
[Note, BQ, MOLDX for example frequently covers tests before commercial insurance does, so incorporating commercial insurance in the gateway considerations would slow down CMS coverage.]
BIO
We support not finalizing R&N rule.
We are concerned about the use of "Medicare patient" in rulemaking, as Medicare patients are diverse.
If there are operational issues in implementing MCIT (re rapid coding and pricing) then that is a signal there are also operational issues for new technologies, regardless of BT status, MCIT rulemaking.
We were disappointed that (in the January Trump rule) diagnostics were included but NOT if they were screening diagnostics. Screening diagnostics are important. [Note, BQ, the rule modified 1861(a)(1)(A), the fundamental R&N clause, so it indeed it would not have applied to screening tests and services.]
Coalition for 21st Century Medicine
If CMS deletes MCIT as it is, then the rule should propose a new approach to BT device coverage as well. CMS could do new rulemaking with proposal and finalization by early 2022.
We support MCIT but CMS could add ideas like coverage rescission based on certain benchmarks.
Digital Therapeutics Alliance
Disappointing that CMS does not recognize digital medtech in the rule. "Digital medical devices do not have a Medicare benefit category and they are not presently covered by Medicare. We ask CMS...to exercise its leadership to explore how existing benefit categories may work...or work with Congressional leaders..."
Detach R&N rulemaking to a separate process.
Masimo
Reject the repeal, implement the rule. Urgent issues face the Medicare population. Masimo has opioid use disorder technologies and "using traditional pathways, these new technologies would take years to reach this at risk population." (E.g. respiratory suppression monitoring.)
MDMA
We submitted detailed comments in favor of, and helping implement, the MCIT. Disappointed by CMS's revocation position. There was overwhelming support for MCIT, quickly develop and finalize a new rule.
Don't codify R&N, no good rationale provided.
Medtronic
We are disappointed. The lengthy FDA review could have been used as a time period for operationalizing implementation for a product.
Use a voluntary opt in process to identify products in BT pipeline that will need MCIT implementation and resolve issues. Ensure flexibility in any CED under MCIT. Options include mfgr-directed evidence and CMS-directed evidence. Implement "beneficiary safeguards" as necessary - don't use bene safeguards as a reason to nix the rule.
MISONIX
We agree that MCIT presented operational issues, and unanticipated scale issues. Separate the R&N rulemaking.
Consider bringing HCPCS coding and CPT and RUC pricing into the MCIT process.
CMS posed many questions on the MCIT process and R&N rule, but few frameworks or answers.
Strongly supports repealing the R&N rule.
PCMA
Pharmaceutical Care Management Association.
The repeal is not that bad because BT products can be adjucated claim by claim, or policies created by LCD and NCD.
The R&N regulation requires clear definitions and the applicability to drugs and biologicals needs discussion. This risks "nationalizing" the coverage process for drugs rather than leaving them "regional" with MACs. Mention of interactions between Part B and Part D policy. Discussion of need to manage high cost drugs.
PHRMA
We invested $91B in R&D in 2020.
We support recission of R&N rule. "Any change must be made with caution." Don't refer to commercial policies, because there are no CMS rules or processes that govern how those decisions come into being.
PMC
Personalized Medicine Coalition, PMC supported the original PMC so it is disappointed by the proposal to nix it. It's important the agency continue to consider alternatives, as promised.
We have concerns with codifying R&N rule. Discussion at length of "safety and effectiveness" (which is incorporated as a bullet under R&N), "appropriateness" (not otherwise defined), and commercial coverage as a factor to be weighed in coverage.
Today, CMS released the Restructured BETOS Classification System (RBCS) – a taxonomy that allows researchers to group healthcare service codes for Medicare Part B services into clinically meaningful categories and subcategories. The RCBS is an update to the Berenson-Eggers Type of Service (BETOS) classification system developed in the 1980s.
Researchers may use the RBCS to analyze trends and perform other types of health services analytic work. The first release of RBCS includes healthcare services between 2014 and 2018. The RBCS will undergo annual updates by a technical expert panel of researchers and clinicians.
To access the RBCS, please visit the following website: https://data.cms.gov/provider-summary-by-type-of-service/provider-service-classifications/restructured-betos-classification-system
###
The Centers for Medicare & Medicaid Services (CMS) recently launched a redesigned data.cms.gov website that makes it easier to discover, access, and understand CMS data. Data.cms.gov gives you direct access to public data released by CMS. Our goal is to ensure that CMS data is readily available in open, accessible, and machine-readable formats. For most available data, you can:
We would love to hear from you! Send feedback on the new site to OEDAUserResearch@cms.hhs.gov.
Zebra Medical got a code for FDA-cleared vertebral fracture screening without human intervention on CT scans. (Films and patients are flagged for human review). The code was passed at the February 2021 meeting, meaning it was published around July 1 in final form and with final code number, for use January 1, 2022.
In July 2021 proposals, CMS proposed to class with "New Proposed" pricing (NP) with status E1 (not payable for Medicare.) It would be not payable on the theory that there is a bone density screening benefit for osteoporosis, but there is not a specific screening benefit just for non human AI VFX screening.
BACKGROUND
Code made a splash in the radiology trade journals.
Officially added on July 1 and set to take effect on January 1, 2022, the new category III code -- 0691T -- would apply to the use of AI for automated analysis of existing CT studies for vertebral fracture(s), including assessment of bone density when performed, data preparation, interpretation, and reporting.
The code was approved by the AMA after representatives from the RSNA, American College of Radiology (ACR), the American Roentgen Ray Society (ARRS), and the Association of University Radiologists initially proposed the code in a presentation at the AMA CPT Editorial Panel meeting in February.
###
https://www.theimagingwire.com/2021/07/12/imaging-in-h1-ai-code-going-corporate/
he American Medical Association issued the first imaging AI CPT codes on July 1st, including Category III codes for incidental vertebral fracture detection and quantitative ultrasound characterization, allowing clinics to start billing for these applications in January 2022 and potentially leading to the first AI reimbursements (the new AI codes are on page 3).
https://www.mwe.com/people/paul-gerrard/
September 2021
Dr Paul Gerrard is a highly regarded physician and healthcare executive with deep experience in both the academic and patient care spaces. He offers clients critical insights across a wide range of clinical areas and healthcare technologies, and provides guidance on Medicare policy and regulatory requirements. Paul also has significant experience in health outcomes research and scientific computing.
Before joining McDermottPlus, Paul served as chief medical officer and MolDX director of clinical science at a commercial provider and Medicare Administrative Contracting company. MolDX has a contract with the Centers for Medicare & Medicaid Services to review and make coverage and payment determinations for new molecular medicine technologies. In this role, he was instrumental in forging consensus among Medicare contractors on emerging and sometimes controversial areas of medicine in a highly visible program, and served as a primary point of contact between MolDX and the Centers for Medicare & Medicaid Services. He also played a critical role in the development of strategic directions for molecular diagnostics, post-acute care, and data analytics.
Prior to that role, Paul worked in private practice in New England, where he advised acute care and post-acute care institutions as well as academic departments on Medicare coverage, billing, and quality measures. In addition to being centrally involved in administrative legal hearings regarding denied payment cases, he also worked closely with various stakeholders to develop a data-driven strategy that was used to enhance care quality and safety, including improving patient satisfaction and hospital readmissions.
Paul served on served on the National Quality Forum Scientific methods panel while in private practice and currently serves on the American Medical Association (AMA) Proprietary Laboratory Analyses (PLA) – Technical Advisory Group (TAG).
Here is a link to a law firm article that private payer recoupments may occur, as well as government payer recoupments (such as OIG/DOJ).
https://www.hollandhart.com/fraud-and-abuse-in-private-payor-situations
http://www.discoveriesinhealthpolicy.com/2021/09/nerd-note-lab-wins-claim-that-lcds.html
https://www.youtube.com/watch?v=piBBRjGG-Fk
AUTO TRANSCRIPT
Unknown Speaker 0:00
And I represent Alex ASR Secretary of HHS who is appellant cross, actually in this case. With the court's permission, I would like to try to reserve five minutes of time for rebuttal. In this case, the district court erred by holding that and a local coverage determination or LCD is covered under the Medicare act rulemaking requirements under Section 1395. h. h. A to under that section, the Secretary is required to engage in notice and comment rulemaking when he promulgate a rule requirement or statement of policy that establishes or changes a substantive legal standard governing payment for items or services. Here, an LCD does not qualify under the plain text of Section 1395. h h. a two for several reasons. First, the Secretary doesn't issue LCDs a local coverage determination is issued by a private contractor and is a determination with respect to a particular item or service that applies solely contract for why it is not a an agency requirement or policy that applies nationwide, such as the one at the Supreme Court.
Unknown Speaker 1:34
Are you saying nationwide coverage? They come under the umbrella of coverage? Is that your position?
Unknown Speaker 1:41
That is one? We think that that when we do think section 1395 ha ha does really does only apply to the nationwide? because by definition, when when the agency is promulgating a war requirement or policy for Medicare, it's it will do so for the program as a whole. But this is but there's other reasons as well, why this stuff move
Unknown Speaker 2:10
out to zero. The reason I'm sure, but just for your initial reason is the opposition that it was not an nit nationwide policy, but it never can be covered because of your position.
Unknown Speaker 2:22
I don't think that I don't think that it could be covered. However, the court does not need to decide that because there are other aspects of this, which distinguish it from the what is covered under 1395. Ah,
Unknown Speaker 2:41
counsel, would it make any difference if you had a service where there was only one provider in the whole country, and it was covered by only one fiscal intermediary decision, even though the services were rendered throughout the country? I mean, the plaintiff in this case contends that basically, for them, where they serve lots of different places, this is sort of like the death penalty for their business. But I could imagine a circumstance where it's like the only provider, would it make any difference to the government in that situation?
Unknown Speaker 3:25
No, Your Honor, because that that would just be a unique factual circumstance of that local coverage determination. As we pointed out in our brief, if you have a test, that a supplier or provider develops somewhere else in the country, even if they there was the situation you described, there could be a provider or supplier that developed a different test that would be covered by a different or you could have another another pipe provider located in a different contractors jurisdiction. But it's the other key point is that even what your honor is referring to would not be binding at higher levels of Administrative Review. The contractor determination is not binding even on qualified independent contractors, which is the next level above reconsideration by the same contractor. It only binds the contractor itself. And it's definite the statutory definition of local coverage determination makes this clear it it actually states that it's covered on an intermediary or carrier wide basis, which is on factor wide basis,
Unknown Speaker 4:42
but it's entitled everywhere to substantial deference, right.
Unknown Speaker 4:47
Under agency regulations, it is, Your Honor. However, the regulations also make clear that at all of those levels of review, that the adjudicators may disagree regard the LCD so long as they give reasons and explanation for doing so.
Unknown Speaker 5:06
Is there anything in the record about how often with particular kinds of LCDs different adjudicators reach on the same issue, different results? That like number one says yes. And number two, when it comes back at another time, it's like the exact same circumstance says, No. Is there anything in the record as to how often that happens?
Unknown Speaker 5:37
I think is the the record in this case shows that that does indeed happen as the Hlj actually rule. Right.
Unknown Speaker 5:45
But that but that's in the same chain, I'm talking like, for a different a different claim. Is there anything in the record about how often there are different results on the same issue?
Unknown Speaker 5:58
Your Honor, I think the fact that there's not It's not that I don't know that there's anything in the record on that. I do know that agenda is cited a report that discussed in consistencies among LCDs. And the need for the Secretary to do more with respect to the statutory process outlined by Congress, which we also think supports our position that a local coverage determination is simply a great hit. They're supposed to be precursors of national coverage determinations. And Congress has directed the Secretary to develop a plan to evaluate new local coverage determinations to determine which should be adopted nationally, it also stated that the contractors themselves should consult. And so there, there is an understanding with the 1000s of appeals nationwide by not just providers, suppliers, but beneficiaries, that just to effectively and efficiently administer the Medicare program, there is going to be some inconsistency at the outset. And that may not be with respect to every service or every medical device, or it can't be with respect to everything. But there's so
Unknown Speaker 7:27
let me see I get some clarity. Maybe you can help me because you're much more experienced in this matter than I am, obviously. But today, this case would not be before us. The statutory scheme has been changed as of 2016. From what I understand. So if this was a case that was being litigated under the current statute, would you agree that this would be an LCD that would be applicable?
Unknown Speaker 7:55
Oh, yeah. Well, yes. In that the the LCD. Are you saying, Your Honor, that if it is true that this particular LCD was not subject to the 2016 separate notice and comment procedure?
Unknown Speaker 8:11
If it were? Yes. Would it not be today is what my question is, it seems like with the with the situations that can repeat again, sort of an outlier case, right, dealing with the prior statutory scheme, such as it is or was missing something?
Unknown Speaker 8:30
Your Honor, I think that under the district court's holding the court appeared to think that this in the future, this type of LCD would have to go through both the 2016 separate process under Section 1395. Why and notice and comment. So I mean, we submit that the answer should be the same, both in this case, and currently with LCDs promulgated now, it is true that since 2016, the LCDs are we're required to go through this process. But we think that process shows confirms that Congress never intended LCDs even prior to 2016. But I don't know.
Unknown Speaker 9:21
It seems to me that what the statute has done now is put in place what in practice has existed before the MA C is involved with the creating DLC beads. Right. And it just seems that that has always been the case. But now it's put into a statutory context. Let me back up a little bit. You know, I I'm sure you've read judge Cavanaugh his decision in the district court case when he was a lowly district court judge right in the lead up, and we're talking about what constitutes a substantive legal standard. It seems to me that that's the bottom line of what we have to determine. And he says that at a minimum includes a standard that creates the fines and regulates the rights duties, it empowers the parties. Do you think that the AMA sees the termination in embracing its LCD or rejecting it meets that standard that it does indeed regulate the rights duties and powers of bodies?
Unknown Speaker 10:20
No, Your Honor, we do not because it doesn't bind any agency adjudicator above the contractor itself. And it doesn't announce the agency's policy with respect to the Medicare program. It's just that contractors. Well, I
Unknown Speaker 10:37
get the position, but let me see whether you can answer these questions. Do you agree that ma C's are required to follow the own LCDs? I think we agree on that. Yes. And here it made indetermination. Right. And if a determination based on an LCD is not appealed, isn't that determination find that there's no appeal? We agree with that. Yes, but we think that they are getting creative, right. Okay. So if don't LCDs create the final regulated claimants right at the initial stage of review the initial stage
Unknown Speaker 11:13
at the very initial stage, but that claimant has the right to appeal to the aggrieved beneficiary and can challenge the LCD directly.
Unknown Speaker 11:23
Here's my next question. Do you agree that LCDs are entitled to substantial deference to male js and the Medicare Appeals Council laid out a substantial deference? I think that's what is required by the agency regulations. Yes. You agree whether we know nlg can be reversed for for you to show substantial deference to an LCD like in this case?
Unknown Speaker 11:48
Yes, if the if the Medicare Appeals Council does not think the reasons they Hlj gave for doing that are sort of we don't build see these continue to regulate the rights of parties at higher levels of review? No, they don't, but they don't establish or change a substantive legal standard because that would have to be adopted by the agency and any,
Unknown Speaker 12:15
any a new sample where it would change a subsequent legal determination. We start off now with an LCD the MA C's have required to follow it right? It can't be changed, because substantial deference has to be given isn't that a change?
Unknown Speaker 12:33
No. Change means like over the change what they're getting at there, I think is if a regulation that the agency has already promulgated is changed by a subsequent regulation or the policy? It's it's not within one case of a standard we get what Assad do you have for that?
Unknown Speaker 12:54
Strange interpretation today. Do you have any so what's your best case that supports that?
Unknown Speaker 12:59
I think, Your Honor, again, I would go back to the statutory text. And if you look at 1395 h h A to it's talking about the secretary shall prescribe regulations as may be necessary to carry out the insurance programs. And then it says no rule requirement or other statement of policy other than a national coverage determination. That it would be we think that completely supports our position as well, because an LCD
Unknown Speaker 13:29
for your sickness has to be a national coverage determination. You're getting back to what you originally said when you began your comments today.
Unknown Speaker 13:37
Well, I think that the the text of 1395 ha ha two is discussing things that are promulgated by the secretary or the agency for the Medicare program as a whole. But you can the statute itself defines as an LCD is something entirely different, and also has a completely separate notice and comment. process that the contractor not the Secretary is required to to follow. And if this court were to affirm the district court, it would require the Secretary to engage in notice and comment rulemaking on something the contractor is already separately engaging in its own notice and comment procedure
Unknown Speaker 14:28
today, and then the new statutory scheme, this is exactly what we acquired today. Why is that such an odd proposition?
Unknown Speaker 14:35
Because it's not required? Your Honor, because it did this is the first court that has ever held that an LCD is covered by 1395 h eight,
Unknown Speaker 14:46
because my ra that under the current statutory scheme that in there was enacted in 2016. Notice and comment would be required of LCDs.
Unknown Speaker 14:56
up but it's an entirely separate process. It's by The contract or it's less formal. It's not the Federal Register is for agency obligations by the secretary. And this is the process in 1395. Why is 45 days not 60? It's on the Medicare and contractor website, not the Federal Register.
Unknown Speaker 15:21
You talk about contractors, but it's the MHC that's doing this, the MLC decides whether to embrace an LCD or not,
Unknown Speaker 15:30
Your Honor, that they these decisions are done in the context of a particular claim or appeal. They are not that the MSE is just deciding whether the DOJ properly did or did not defer to the LCD and whether there are reasons to depart from it. With respect to the particular like, in this case, the particular diagnostic test use the MSA with the the Appeals Council. I don't want to say MVC, because MVC is a Medicare administrative contractor. Council. So I don't want to confuse that. But now, who wants to determining whether an LCD should or should not be embraced? That's what is that
Unknown Speaker 16:12
that's what they're there for. They listen to advice, they get information from professionals people comment about it. It's a substantive determination. And you agree that that is absolutely a final determination. If there were no appeal, you agreed to that.
Unknown Speaker 16:27
But that doesn't, that's only if there's, but it's not binding on anyone but that contractor, and it's up to the individual whether or not they want to challenge it. And in the absence of an LCD, it would be just as binding on the provider or beneficiary, if the contractor would still be required to determine and this Court said this in eringer, B. Thompson, that what the contractor is doing is just interpreting the statutory, reasonable and necessary standard, which is the substantive standard here. It's a statutory standard, which the contractor is interpreting. And the LCD just allows the contractor to be more transparent about.
Unknown Speaker 17:15
And counsel, the argument that you just made was an argument that the government chose not to make in the aleena case, as the Supreme Court's opinion points out, saying that the result might have been different had the government made that that argument, is that correct?
Unknown Speaker 17:34
i? Yeah. I mean, there there are different there are different statutory standards that were at issue there. It wasn't a reasonable and necessary case. But yeah, so in here, there is a we are making the argument, this Court has a party held with respect to LCDs. And that is what you're doing in that situation.
Unknown Speaker 17:57
And but I just asked one, one last question, and then we'll give you a little bit of time for rebuttal. But do you think that we should use the DC circuit's definition of substantive legal standard from the DC Circuit opinion? And Alina?
Unknown Speaker 18:11
Um, whether or not you do we would win either way? I mean, because for all the reasons I've given. So you know, I'm not taking a position on that in this case. But I think we think even if you apply the DC Circuit standard, this clearly for the reasons given that it's promulgated by a contractor applies only contractor wide, and it's simply the contractor interpreting for a particular item and service, whether it's reasonable and necessary,
Unknown Speaker 18:44
what would be the practical result today. And in the opposition, with the practical results today, this was happening today.
Unknown Speaker 18:55
Practice practical result would be that the that the new LCD would go through the contract or notice and comment procedure, and that's outlined in the statute. Okay.
Unknown Speaker 19:10
So I'll still give you a couple minutes for rebuttal, because we took you off to a good time. But let's hear from you, Your Honor. Mr. Hooper, in the meantime,
Unknown Speaker 19:18
Thank you, Your Honor. may it please the Court Patrick Cooper for agenda EC council began her argument by saying and stressing that the Secretary didn't issue this policy. And it's not of national. It doesn't cover the entire nation. In my mind, that is a fairly major admission about why we contend This is too much power being given to a Medicare contractor. This is a very significant policy. And the fact that the Secretary does an issue, it triggers the delegation issue that we've identified now recognize that's always an uphill battle. But as you know, in our cross appeal, we thought, if ever, there's a case where a private party has too much authority, it's this situation. And if counsel, if the Secretary had actually actually issued this case, and then national in scope, then that would have been what constitutes a national coverage determination. And we wouldn't be here looking at the impact of a local coverage determination. This is a classic local coverage determination that impacts the United States. If you are a all beneficiaries in the United States, if your doctor, your breast, Pat, a cancer patient, and your doctor orders these very important test to be done, the only provider in the country that can provide these particular tests his agenda, and wherever you are in the country, it will perform the test. And it will be unfortunately denied coverage because of this local coverage determination. So I don't know how you could be. And I don't know how there could be any more of a national impact than this kind of situation.
Unknown Speaker 21:25
So looking at the statute, as it was at the time of this decision. So before the 2016 amendments, why would it make sense for LCDs to have a higher level of notice and comment requirement than the national standards?
Unknown Speaker 21:43
Yes, that's a get I get that, Your Honor. I think when your honor looks at the coverage, it looks at the promulgation process for national coverage determination. I think it is virtually the same, there may be a 30 day as opposed to a 60 day notice period. But the national coverage determination is coming out of the government, with government folks doing it. And there is this independent process it has to go through. I don't think making the LCDs go through the H H, the 1395 h h process is more onerous than going through the national coverage
Unknown Speaker 22:30
Council, as I understand the district court's ruling, that if we affirmed, then the LCDs would now have to go through both. Is that right? They would have to go through the process in the statute, and they would have to go through the normal Federal Register, the agency would have to do the normal Federal Register agency and comment is that right?
Unknown Speaker 22:54
That's what the court said. The court said, That's not they're not mutually exclusive. And I think if you look very hard at the 1395 process, that is a separate process, in my mind, that is intended to get a certain audience to input involved, but then they get the public input. I would think the you'd have to go through the traditional rulemaking, the answer is yes. Your
Unknown Speaker 23:27
position that currently, the LCDs should have to go through both processes.
Unknown Speaker 23:34
Well, that's the district courts position. I think it is sound And who am I do second guessed this, the district court and this, but I think
Unknown Speaker 23:45
we would be looking at that de novo. So what do you think we should say?
Unknown Speaker 23:49
Well, I think that it should go through the H H, excuse me, the 1395 h h process. And before that process, I believe it should go through the 1395. Why process? So yes, but they don't they aren't. They aren't the same when you're really new. And
Unknown Speaker 24:09
you think it's you think it's false plausible, that that's what the Congress intended?
Unknown Speaker 24:20
Well, it seems to me they don't like to go through if it's identical. There's no need to go through both that I don't think they're identical. Your Honor, as I said before, and I think as Judge block pointed out, I think 1395 kind of memorialized what was going on already with the Medicare administrative contractors. They had this kind of de facto process where they would try to get people, doctors involved and others involved, but it wasn't the same process as required on the 1390 Five h h, which is going to involve everyone, including members of the public, including doctors, others who may not even know. So I think they're separate processes. That's that's counsel.
Unknown Speaker 25:14
counsel, one thing that I want to make sure you address. So my biggest concern with your argument moving away from the delegation argument, is that the, for you to win this has to establish or change a substantive legal standard, governing the scope of benefits. And the government has argued with some force that the substantive legal standard is in 1395, why a one a reasonable and necessary, and that no matter what the LCDs do, or promulgate The only substantive legal standard governing on these issues are reasonable and necessary. So they couldn't possibly these LCDs couldn't possibly change it. And if that's right, you lose on this issue. Why are they wrong?
Unknown Speaker 26:14
Well, Your Honor, I think that was addressed by the court, and Elia. Because a couple reasons. One, as we all know, the statutes contain very general provisions. We're talking about, you know, 1000s and 1000s of services that are provided health care services. No one I think can reasonably read reasonable and necessary as answering the question for each service. Therefore, there's a gap. And I think this is a classic gap
Unknown Speaker 26:52
filling policy. But counsel in a line of the Supreme Court said separately, we can imagine that the government might have sought to argue that the policy at issue here didn't establish or change a substantive legal standard, because the statute required itself to count Part C patients in the Medicare fraction. And here, the government's argument is the statute itself requires reasonable and necessary, and that's the only substantive legal standard here, not whether one test that Mr. Smith or Mr. yoshiwara got was reasonable or necessary.
Unknown Speaker 27:31
Well, this policy that we're looking at impacts much more than agendas, molecular diagnostic testing this in this particular case, and that point might be applicable if we were dealing with a specific kind of procedure. Where you could say the LCD is limited to a particular proceeding, kind of procedure. But Your Honor, I think in this case, this is a very unique national power, excuse me, local coverage determination, because it says, All my neck all my life to have diagnostic tests, not just the molecular diagnostic test here, that all of them that are done by laboratories throughout the country. And this is a very, very important Phil's got some
Unknown Speaker 28:20
counsel as your argument that some LCDs have to go through notice and comment and some don't.
Unknown Speaker 28:28
Yes, I think I think I would agree with that. And in this case, to me, the the simple answer is, as a substantive legal standard is that we had an administrative law judge say that we should agenda should be covered in this particular the testing should be covered. But solely due to this lcsd agenda is not having as testing cover. That's not a procedural or an interpretive rule. That is a change in substance. And and I realize I'm applying it to a case now. But what this policy did was establish didn't change, it established a new policy for all molecular diagnostic tests. You can read reasonable and necessary all you want, Your Honor. And I don't think anybody can say one way or another whether Congress dealt with that issue. This is one of those classic, very, very broad delegation.
Unknown Speaker 29:26
I asked you this I'm a little confused, you know, with one view of this is that the standard is reasonable and necessary. And this has to be changed to what unreasonable and unnecessary. I don't understand what that means. I think that there could be changes in terms of how you go through the process where the differences do or not do. I understand that can change the dynamics, but how do you change from reasonable and unnecessary to something that's not reasonable and
Unknown Speaker 29:55
what else I that if I understand that judge and if that were the case If the administrative law judge had not made a finding that this was reasonable and necessary, I would say that's a problem. Because that the statute is controlling. We always argue in these cases, and we put on evidence to show the statute is controlling, and we had an expert oncologist. And we also had other folks testify at the hearing, and we canceled this
Unknown Speaker 30:25
suit. So does that mean that in your view, what converts this statute into one that requires notice and comment is simply the substantial deference part? And that without that there wouldn't need to be noticed some comment?
Unknown Speaker 30:39
Well, that? I think, to answer that, Your Honor, I think it's not necessary, that that regulation came into power to all of a sudden make that that made it much more difficult. In this case, it made the LCDs, virtually rubber, the agencies had the rubber stamp them. But I think in this particular case, though, that you did not have to add to reach that particular point.
Unknown Speaker 31:13
Okay, I just asked you I wasn't understanding I don't think from your briefs that you were arguing that some LCDs needed notice and comment, but not others. Could you explain which ones needed and which ones don't? Well,
Unknown Speaker 31:28
no, I I honestly cannot explain that I am only dealing with the one here, which was an extremely broad LCD that had national impact. And in that situation, I'm not saying this Court has to make a ruling that affects all local coverage determinations. But does look every
Unknown Speaker 31:47
contractor is announcing an LCD. How does it know whether it needs to do notice and comment first, in your view?
Unknown Speaker 31:55
Well, I think it would be the secretary that should make that determination. And I think when there is a secretary isn't usually involved in the formation of the Right, right, and that's one of the problems and and by the way, I want to come back to judgment there. I lost my thought for a second. But I want to just say, in response to judge Freeland, that, in this particular case, the the LCD was binding on the initial determinations, and that's why we made that's why we cited the Federal Circuit case recently, because it had
Unknown Speaker 32:35
confused with the with the contractor who's issuing the LCD, you know, necessarily whether there was someone else in the country who in a different region who was offering a similar product or service.
Unknown Speaker 32:49
Well, in this case, there's only one, there's only when you have these kind of tests, these molecular diagnostic tests. They are a unique laboratory tests. And only one laboratory provides these particular tests. There are other kinds of breast cancer testing that are provided by other laboratories. But these are unique tasks. And there's only one in the country that does it. And but with the contractor No, that that was my question. Yes, absolutely. They absolutely know what, Your Honor. They don't I'm sorry, please, please go ahead and finish your answer. Did you know that that's, that's exactly what why they have this modex process, because they know all of these molecular diagnostic tests are run by different companies. And they expect each company to come through this process and prove the medical necessity.
Unknown Speaker 33:43
I don't mean this to be a flip question. So it may sound that way. But I don't mean it to be that way. But so are you suggesting that our ruling in this case? Should it be that this particular LCD needed notice and comment? Some do some don't. And we end there and leave it to the next court to decide which do and which don't?
Unknown Speaker 34:10
Well, I think a line of did a little bit of that, Your Honor. And I wish there was a bright line, but all I know is this one, which says all molecular diagnostic testing, none of it is covered until we approve it. That to me, is broad enough and chain and establishes a new legal standard that in this case, the court can say this one should have been promulgated as a regulation. I'm not certain the contractor would even know what the Administrative Procedure Act is wrong. That's one of our problems here. These are not government people. This this is the medical director at a private insurance company who decided the fate of all these molecular diagnostic tests. That's why we're so troubled by the delegation in this case. No, I can't say for sure getting back to you judge Freeman. I can't say for sure they wouldn't know what which ones have to go through which ones. So it was I think Jerry needs to come into this and straighten it out, due respect me criticized by their own Inspector General. But we want coverage determination there. And it goes, I think judge block is trying to ask the question, if it's a little hard to hear,
Unknown Speaker 35:21
heard or not now with this wonderful system we have, but I'd like to ask you this. Tell me whether I'm wrong here. Seems to me we're talking about who is that person, Shakespeare's Much Ado About Nothing? That, you know, all you're asking is that the same process that exists today should have been implemented way back before the new statute came into existence that obviously, they will be doing it today. And they should have been doing it before. And we're really talking about a sort of an outlier situation, which is not likely to repeat. And it seems to me, it's as simple as that. These are rights that are being determined that final by the NAC, and they can be subject to appeal, they can be given deference, they can be changed. Seems to me that that's what you're trying to say. But I'm a little bit muddled in how you're trying to articulate yourself. Well.
Unknown Speaker 36:10
That's why you're the judge. And I'm the lawyer. But no, i i agree. Your Honor. You I think you've identified it. I accept that what got me a little thrown off there was that the district court does seem to say there should be two processes. And that's that's that's not easy to reconcile unless they're two separate processes. But using your reasoning that the process definitely applies once 2016. Yes, you could conclude they should have done that.
Unknown Speaker 36:40
What is the process today are the two processes under the new statute? I'm a little confused.
Unknown Speaker 36:46
That's that's what I would say. One is what I would call a preliminary. Why is a legislative process. Another is the traditional
Unknown Speaker 36:58
rulemaking. It's the same that existed before in practice, which is now being formalized by the new statute, correct.
Unknown Speaker 37:09
Okay, we've taken you over your time. Thank you. I will give Ms. Marcus, two minutes for rebuttal. You're muted?
Unknown Speaker 37:22
I'm sorry. Thank you, Your Honor. I first wanted to respond to and it led was counsels seeming argument that it would be specific LCDs, some would be subject to 1395. And some wouldn't. And that's completely impractical under the Medicare statute, and the whole administrative appeals process. Practical today. But it also be equally impractical. Yes, Your Honor. And today, the LCDs do need to go through the contractor led more informal process that Congress itself requires in 1395. Why? That's undisputed that that that applies, however, to have the secretary engage in rulemaking for you know, hundreds of LCDs and some some of which, as we pointed out, you could have two different LCDs. And then there'd have to be a separate determination about whether this LCD is better or not.
Unknown Speaker 38:30
LCDs did two different MHC determinations, how many ma C's do we have in the country today? 10 1112? Five? I think it's around that, Your Honor. All right. So these are not all sorts of LCDs is ma c determinations. And Congress in its wisdom decided this type of process would be the best process, rather than to have a national process in the first instance. And these ma sees the dynamics lead ultimately to MIT's so why should we not have the same opportunity for people to comment and interact with the pro video these particular determinations?
Unknown Speaker 39:06
Oh, but they do, Your Honor. There's the local coverage determination process under 1395 allows for that. And, and the contractor has to not only put it on its own website, but on the Medicare internet website, at least 45 days before the effective date. And the public has a chance to comment but I would just direct your honor to the provisions about national coverage determinations, which again, are expressly excluded from 1395. h. h. A to those are what the Secretary is supposed to consider, you know, LCDs for possible creation of a national coverage of termination and that beneficiaries can request that the Secretary do so and the Secretary there's also a process in 1395 why for national coverage determinations, the same statutory subsection as governs notice and comment for LCDs. It's separate and different. And exclusive from 1395, h, h, and LCDs. And ncds are expressly mentioned in 1395. Why?
Unknown Speaker 40:22
To get it the wise Q's double x to the double A tos. And that seems to be amazed, because I never had any exposure to this. I apologize for my ignorance. But we're talking about the same thing today, as existed before in the real world now has been formalized in a structured way. I don't see the difference between before and now maybe you can explain to me what we're talking about?
Unknown Speaker 40:46
No, I think to some extent, Congress was in its provisions about LCDs, formalizing what was happening with the contractors, again, just interpreting the substantive legal standard that is there on the statute, the reasonable, unnecessary standard, what would be the huge change? We
Unknown Speaker 41:05
change, but you're suggesting I have to interrupt us? What are you telling me that we'd have to have a change from reasonable unnecessary to unreasonable and unnecessary? What kind of change are you talking about?
Unknown Speaker 41:21
I yes, I think that's what i mean that the substantive legal standard is in in the statute, and there isn't that necessary? How can I be paged? But Your Honor, again, that the contractors are interpreting that standard for only the particular item and service for that claimant? These are very, it's called a determination, not a rule requirement or policy. It's an individual determination. If it is National scope, and it's going to cover everything, then you have a different process set forth in 1395. Why, but it's still not the notice and comment 1395 h. h standard, and that shows that Congress made sure you're not relegating form over substance here, Counselor? Yes, I am sure, because of the fact that it would make no sense to have national coverage determinations, excluded from the more formal Federal Register policy fact your presumption that there has to be
Unknown Speaker 42:27
a national coverage. That's the only thing that applies,
Unknown Speaker 42:31
right. And that even for an N and Congress has recognized for this particular statutory standard, that even with national, the National ones don't
Unknown Speaker 42:42
have a comment or, you know, comments and notices ever needed even now, and this is National determination. Is that your position?
Unknown Speaker 42:49
Oh, no, Your Honor. We are saying that for both national and local coverage determinations that interpret the reasonable and necessary standard, they do have to go through notice and comment, but it's a different type of notice and comment procedure that is set forth in 1395. Why? And Congress recognized that it the agency didn't need to go through the 1395 h h procedure.
Unknown Speaker 43:20
Can I can I just ask. So in this, the 2016 amendment that added the in sort of less formal notice and comment procedure for LCDs. It sounds like you and judge block might know about the history more than I do. So was that happening informally? Already? The posting on the website? Is it?
Unknown Speaker 43:38
Your Honor, I don't know. And I'm sorry. I don't I mean, there, I assume. And before that happened, there was an LCD proc some type of process that contractors were doing. I do not know if they were doing and then maybe the purpose of this was made sure it was consistent among contractors and save the record. I don't know how many days I don't know if you had a doctors who were the MA see doctors were making these judgments if they didn't do this and a clear blue sky, if they have professional representation studies, and they reach out to the public and other medical people to make a reasoned determination. I mean, I'm sure that was happening before. Do you take issue with that? I don't take issue with it. I'm not sure I do know that there was some kind of procedure set up and Congress recognized the whole idea of local coverage determinations when it actually defined the term in the statute, which was well after the 1395 h provision, so there was no need to expressly exclude LCDs then and then it was already implicit because Congress in 2003, included the provisions about the secretary basically examining LCDs and put as potential precursors for a national coverage determination.
Unknown Speaker 45:00
So, because we're way over time, sorry. But thank you both sides for the very helpful arguments. This case is submitted. And we are adjourned for the day. Thank you both so much. Thank you. This court for this session stands adjourned.
